Eisai’s Zonegran receives EU approval for paediatric use

Eisai has announced that its antiepileptic agent Zonegran has been approved for use in the treatment of paediatric patients by the European Commission.

A licence extension application submitted by Eisai's UK division has been ratified by the regulatory body, permitting the use of adjunctive Zonegran in the treatment of partial seizures among patients aged six years and above.

Data from a phase III clinical trial called Study 312 revealed that the drug was able to deliver a significant reduction in seizure frequency among young patients, when compared to placebo.

Zonegran has been approved for use among adults with epilepsy since March 2005, but this is the first time that children will also be able to benefit from the use of the therapy.

The company said: " By offering multiple treatment options … Eisai seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients with epilepsy and their families."

Last month, Eisai commenced work on an expansion of its UK production facilities in Hatfield, Hertfordshire, which will be completed midway through next year and will support the launch of several new products.